Sickle Cell Disease Clinical Trial
— ESCORT-HUOfficial title:
ESCORT-HU : European Sickle Cell Disease Cohort - Hydroxyurea
| NCT number | NCT02516579 |
| Other study ID # | ESCORT-HU |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 2009 |
| Est. completion date | March 20, 2019 |
| Verified date | March 2020 |
| Source | ADDMEDICA SASA |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
In the context of the Risk Management Plan (RMP), as requested from Addmedica by the EMEA, to collect information about long-term safety of Siklos® (hydroxycarbamide) when used in patients with Sickle Cell Disease.
| Status | Completed |
| Enrollment | 1906 |
| Est. completion date | March 20, 2019 |
| Est. primary completion date | March 20, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 2 Years and older |
| Eligibility |
Inclusion Criteria: - Male or female ambulatory patients, aged 2 years and more (children, adolescents or adults) - With symptomatic sickle cell syndrome - Treated with Siklos® - Having been informed of the study by the initiating physician and consenting to participate to the cohort. |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU d'Amiens - Picardie - Site sud | Amiens | |
| France | Centre Hospitalier Robert Ballanger, pédiatrie et néonatalogie | Aulnay-sous-Bois | |
| France | Hôpital Avicenne; médecine interne | Bobigny | |
| France | Hôpital Jean Verdier; médecine interne | Bondy | |
| France | Hôpital Jean Verdier; pédiatrie | Bondy | |
| France | CHU Bordeaux, urgences pédiatriques | Bordeaux | |
| France | Hôpital Saint-André | Bordeaux | |
| France | CHU Estaing, pédiatrie | Clermont Ferrand | |
| France | Hôpital Louis Mourier; pédiatrie | Colombes | |
| France | Hôpital Louis Mourier; service de pédiatrie | Colombes | |
| France | Centre hospitalier intercommunal de Créteil | Créteil | |
| France | Hôpital Henri Mondor, centre de la Drépanocytose | Créteil | |
| France | Centre Hospitalier de Gonesse, médecine interne | Gonesse | |
| France | Centre Hospitalier de Gonesse, pédiatrie | Gonesse | |
| France | CHU de Grenoble | Grenoble | |
| France | CHU de Grenoble, hôpital Couple Enfant | Grenoble | |
| France | CHU de Limoges | Limoges | |
| France | Hôpital Mère-Enfant | Limoges | |
| France | Hôpital Edouard Herriot, hémovigilance | Lyon | |
| France | Institut d'Hématologie et d'Oncologie Pédiatrique | Lyon | |
| France | CHU Timone | Marseille | |
| France | Hôpital de la Conception, médecine interne | Marseille | |
| France | Centre Hospitalier Intercommunal André Grégoire | Montreuil-sous-Bois | |
| France | CHU Nantes, Hôpital Hôtel Dieu | Nantes | |
| France | Hôpital Européen Georges Pompidou | Paris | |
| France | Hôpital Necker enfants, maladies infectieuses et tropicales | Paris | |
| France | Hôpital Necker; biothérapie | Paris | |
| France | Hôpital Necker; maladies infectieuses et tropicales | Paris | |
| France | Hôpital Robert Debré, immunologie-hématologie pédiatrique | Paris | |
| France | Hôpital Trousseau; pédiatrie générale | Paris | |
| France | CHR Reims, American Memorial Hospital | Reims | |
| France | CHU Rennes, Hôpital Pontchaillou | Rennes | |
| France | CHU Rennes, hôpital Sud | Rennes | |
| France | CHU Charles Nicolle | Rouen | |
| France | CHU de Rouen - Hôpital Charles Nicolle | Rouen | |
| France | Centre Hospitalier Delafontaine, médecine interne | Saint-Denis | |
| France | Centre Hospitalier Delafontaine, pédiatrie | Saint-Denis | |
| France | CHRU Strasbourg, Hôpital de Hautepierre | Strasbourg | |
| France | CHU Toulouse; hôpital des enfants | Toulouse | |
| France | Institut Universitaire du cancer; médecine interne | Toulouse | |
| France | CHU Nancy, Brabois enfants | Vandoeuvre-lès-Nancy | |
| French Guiana | CH André Rosemon | Cayenne | |
| French Guiana | CMCK | Kourou | |
| French Guiana | CH Ouest Guyanais | Saint Laurent du Maroni | |
| Germany | Charité-Universitätsmedizin, Berlin | Berlin | |
| Germany | Pädiatrie Klinikum Delmenhorst | Delmenhorst | |
| Germany | Heinrich-Heine Universität Düsseldorf | Düsseldorf | |
| Germany | University of Freiburg | Freiburg | |
| Germany | Universitätsklinikum Hamburg-Eppendorf | Hamburg | |
| Germany | München | München | |
| Greece | Laiko General Hospital | Athens | |
| Guadeloupe | CH Basse-Terre, adultes | Basse-Terre | |
| Guadeloupe | CH Basse-Terre, enfants | Basse-Terre | |
| Guadeloupe | CHU Pointe à Pitre | Pointe-à-Pitre | |
| Italy | Clinica Pediatrica AOU | Napoli | |
| Italy | Azienda Ospedaliera-University of Padova | Padova | |
| Italy | Azienda Ospedaliera Universitaria Integrata (AOUI Verona) | Verona | |
| Martinique | CHU Fort de France | Fort de France | |
| Martinique | Hôpital Pierre Zobda-Quitman | Fort de France | |
| Martinique | CH Lamentin | Le Lamentin |
| Lead Sponsor | Collaborator |
|---|---|
| ADDMEDICA SASA |
France, French Guiana, Germany, Greece, Guadeloupe, Italy, Martinique,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | % of Patient-years With Malignancies | During the follow-up of participant, up to 10 years | ||
| Primary | % of Patient-years With Skin Ulcerations | Patients with at least one skin ulceration | During the follow-up of participant, up to 10 years | |
| Primary | % of Patient-years With Myelosuppressions | Patients with at least one myelosuppression | During the follow-up of participant, up to 10 years |
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